WRITTEN QUESTION No. 1538/97 by Hiltrud BREYER to the Commission. Phosphate ester poisoning due to the use of Tiguvon (Fenthion) manufactured by Bayer Leverkusen
Date: 1997-05-05
Institutions: BREYER, European Parliament
Subjects: European Medicines Agency, animal health, domestic animal, insecticide, public health, toxic substance, veterinary drug

C 21/66

EN

Official Journal of the European Communities

22. 1. 98

pharmatoxicological  and  clinical  standards  and  protocols  in  respect  of  the  testing  of  veterinary  medicinal
products (1).  A  product  used  for  ectoparasitic  control  may  have  potential  neurotoxic  properties  at  certain
concentrations and elevated doses. Products which may exhibit neurotoxic effects may be authorised and such
effects may lead to organic lesions with subsequent behavioural changes if the product is abused. The safety of
the  recommended  dose  is  to  be  considered  in  the  assessment  of  the  safety  file  submitted  to  the  competent
authority to support the application for market authorisation (2).

If no such effects are seen at the recommended dose and if the product is used as indicated on the label there
should be no cause of concern. The absence of reports on serious adverse reactions indicates that this is currently
the case.

(1)  OJ 317, 6.11.1981, as amended by Council Directives 90/676/EEC OJ 373, 31.12.1990, and 93/40/EEC OJ 214, 24.8.1993.
(2)  Provision concerned.

(98/C 21/156)

WRITTEN QUESTION E-1538/97

by Hiltrud Breyer (V) to the Commission

(5 May 1997)

Subject: Phosphate ester poisoning due to the use of Tiguvon (Fenthion) manufactured by Bayer Leverkusen

The  flea-repellant  Tiguvon  (Fenthion)  manufactured  by  Bayer  Leverkusen  can  be  administered  in  different
forms. Tiguvon 10 is intended for cats over 2 kg in weight. The use of Tiguvon 20 is recommended for dogs
weighing between 3 and 10 kg, while dogs with a body weight of more than 10 kg should be treated with Tiguvon
20 G. People who have repeatedly treated their pets with Tiguvon (Fenthion) have suffered serious phosphate
ester poisoning. As it was unable to answer my Question E-1470/96 (1) on the same subject, I would ask the
Commission to answer the following questions as a matter of urgency:

Is the Commission aware of any research findings that reveal the extent of the danger to pet-owners, especially
children, whose health may be damaged even by small quantities of toxins and who, at their young age, cannot be
assumed to act responsibly?

(1)  OJ C 345, 15.11.1996, p. 76.

Answer given by Mr Bangemann on behalf of the Commission

(23 June 1997)

Following  the  Honourable  Member(cid:146)s  earlier  written  question  E-1470/96  the  Commission  has  asked  the
pharmacoviligance working party of the scientific committee for the evaluation of veterinary medicinal products
to report on adverse effects of the product. No adverse effects have been reported since then.

(98/C 21/157)

WRITTEN QUESTION E-1546/97

by Hiltrud Breyer (V) to the Commission

(5 May 1997)

Subject: Phosphate ester poisoning due to the use of Tiguvon (Fenthion) manufactured by Bayer Leverkusen

The  flea-repellant  Tiguvon  (Fenthion)  manufactured  by  Bayer  Leverkusen  can  be  administered  in  different
forms. Tiguvon 10 is intended for cats over 2 kg in weight. The use of Tiguvon 20 is recommended for dogs
weighing between 3 and 10 kg, while dogs with a body weight of more than 10 kg should be treated with Tiguvon
20 G. People who have repeatedly treated their pets with Tiguvon (Fenthion) have suffered serious phosphate
ester poisoning. As it was unable to answer my Question E-1470/96 (1) on the same subject, I would ask the
Commission to answer the following questions as a matter of urgency: